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STRYKER CORP., MEDICAL DIV.

USA · Kalamazoo

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

27listed device types

Class I 14Class II 13Class III 0

plus 29 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 27Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

26registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

53active device licences

Class II 47Class III 6

189 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States29 registration records, 20 510(k), 0 PMA, 77 excluded

Brazil28 confirmed, 23 excluded

Saudi Arabia26 confirmed, 9 excluded

Canada53 confirmed, 13 excluded

Manufacturer names merged into this page: STRYKER MEDICAL · STRYKER ENDOSCOPY, A DIV. OF STRYKER CORP. DBA STRYKER ENDOSCOPY · STRYKER CORP., MEDICAL DIV. · Stryker Medical

FDA 510(k) clearances by year

11991

21992

51994

11995

22007

12008

12010

12011

12012

12013

12016

12017

12018

12023

FDA listed device types

showing 8 of 27

Stretcher, Hand-Carried 1Cushion, Flotation 1Board, Cardiopulmonary 1Monitor, Bed Patient 1Protector, Skin Pressure 1Stand, Infusion 1Chair, Examination And Treatment 1Cover, Mattress (Medical Purposes) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222818	Xpedition Powered Stair Chair (625700000000)	2023-01-24
US	K180834	Altrix Precision Temperature Management System	2018-08-10
US	K171149	Altrix Temperature Management Wraps	2017-07-18
BR	80005439001	MACA HOSPITALAR STRYKER	Class I
BR	80005430588	MACA PERFORMANCE-PRO XT STRYKER	Class I
BR	80005430393	MACAS PARA TRANSPORTE PRIME MANUAIS	Class I
SA	ME0000000992SFDAA00184	fFoam Mattress	—
SA	ME0000001368SFDAA00002	Foam Mattress	—
CA	212	PATRIOT DISPOSABLE ARTHROSCOPY CANNULAS	Class II
CA	1529	HERMES CONTROL SYSTEM	Class II
CA	3848	QUADRACUT ACL SHAVER SYSTEM	Class II

STRYKER CORP., MEDICAL DIV.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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